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FDA 510(k)

QUICKVUE RSV 10

K-Number: K101918 · 2010-09-24

ApplicantQuidel Corp.
Decision Date2010-09-24
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUICKVUE RSV 10 is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 2010-09-24 under 510(k) number K101918. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKVUE RSV 10?

QUICKVUE RSV 10 is a medical device that received FDA 510(k) clearance on 2010-09-24. The listed applicant is Quidel Corp.. The 510(k) number is K101918.

When did QUICKVUE RSV 10 receive FDA 510(k) clearance?

QUICKVUE RSV 10 received FDA 510(k) clearance on 2010-09-24, under 510(k) number K101918.

Who is the listed applicant for QUICKVUE RSV 10?

The FDA 510(k) record lists Quidel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUICKVUE RSV 10?

The FDA product code for QUICKVUE RSV 10 is GQG.

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Other records listing Quidel Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+B

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Related Devices (Code: GQG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K240280Nano-Check™ RSV TestNano-Ditech CorporationK162911Sofia RSV FIA on Sofia 2 analyzerQuidel CorporationK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson & COK132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVBecton, Dickinson and CompanyK130398SOFIA(R) RSV FIAQuidel Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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